Pilot Study to Evaluate 18F-fluorodeoxyglucose (FDG) Positron Emission Tomography /Computed Tomography (PET/CT) in Prediction of Early Response to Chemotherapy in Ovarian Cancer.
2012年1月6日 更新者：Memorial Sloan Kettering Cancer Center
We hypothesize that 18FDG Positron Emission Tomography (FDG PET) imaging, carried out after the first cycle of chemotherapy, will identify responders, thus permitting early termination of potential toxic therapy in non- responders leading to a significant decrease in morbidity and cost.
The value of PET imaging as an early predictor of response to chemotherapy has been shown in other cancers.
研究概览
研究类型
介入性
注册 (实际的)
9
阶段
- 第一阶段早期
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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New York
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New York、New York、美国、10065
- Memorial Sloan Kettering Cancer Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Histologically proven ovarian cancer at diagnosis of any stage.
- Patients with evidence of disease that is radiographically measurable (CT scan)
- Patients have planned to undergo standard chemotherapy. Dose and schedule will be determined per treating physician
Exclusion Criteria:
- Patients with any other malignancy active within 5 years except for non-melanoma skin cancer, or carcinoma in situ of the cervix.
- Patients with an active infection
- Patients of childbearing potential are excluded from this study.
- Patients who have expected survival < 3 months.
- Patients not planning or able to receive the outlined chemotherapy regimen as part of standard practice.
- Patient unable to complete study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：1
The study will evaluate the potential of PET imaging to identify early responders to chemotherapy.
Patients entered into this study will undergo FDG PET within 2 weeks prior to chemotherapy and prior to initiation of the second course of chemotherapy.
All images will be carried out in the same manner with respect to equipment, acquisition parameters, and time post injection, to ensure that changes in standard uptake value(SUV) correlate with metabolic changes.
This will be correlated with response determined by changes in serum CA 125 levels.
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The study will evaluate the potential of PET imaging to identify early responders to chemotherapy.
Patients entered into this study will undergo FDG PET within 2 weeks prior to chemotherapy and prior to initiation of the second course of chemotherapy.
All images will be carried out in the same manner with respect to equipment, acquisition parameters, and time post injection, to ensure that changes in standard uptake value(SUV) correlate with metabolic changes.
This will be correlated with response determined by changes in serum CA 125 levels.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Partial metabolic response (PMR) - A reduction of a minimum of 15-25% in tumour 18FDG SUV after one cycle of chemotherapy, and greater than 25% after more than one treatment cycle.
大体时间：Conclusion of the study
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Conclusion of the study
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Partial metabolic response (PMR) - A reduction of a minimum of 15-25% in tumour 18FDG SUV after one cycle of chemotherapy, and greater than 25% after more than one treatment cycle.
大体时间：Completion of study
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Completion of study
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Complete metabolic response (CMR) - Complete resolution of 18FDG uptake within the tumour volume so that it was indistinguishable from surrounding normal tissue.
大体时间：completion of study
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completion of study
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Progressive metabolic disease- increase in 18FDG tumour SUV of greater than 25% within tumour region defined on the baseline scan, visible increase in the extent of 18FDG tumour uptake (>20% in the longest dimension).
大体时间：completion of study
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completion of study
|
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Stable metabolic disease (SMD) -An increase in tumour 18FDG SUV of less than 25% or a decrease of less than 15% and no visible increase in extent of 18FDG uptake in tumor (>20% in the longest dimension).
大体时间：completion of study
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completion of study
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Neeta Pandit-Taskar, MD、Memorial Sloan Kettering Cancer Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2004年6月1日
初级完成 (实际的)
2008年11月1日
研究完成 (实际的)
2008年11月1日
研究注册日期
首次提交
2008年1月25日
首先提交符合 QC 标准的
2008年2月19日
首次发布 (估计)
2008年2月21日
研究记录更新
最后更新发布 (估计)
2012年1月9日
上次提交的符合 QC 标准的更新
2012年1月6日
最后验证
2012年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.